Method and apparatus for making fluid delivery device

ABSTRACT

A method and apparatus for the high volume manufacture of fluid infusion devices which embody a self-contained, stored-energy source for expelling fluids from the reservoir of the device into an ambulatory patient at precisely controlled rates over extended periods of time. In accordance with the method of the invention, the base and cover infusion components of the devices of the invention are manufactured in injection molded arrays which comprise a cover array which is superimposed over and connected to a base array with the elastomeric membrane being captured therebetween. The elastomeric membrane material, which forms the stored-energy source of the infusion devices, is continuously unrolled from a large roll of film-backed membrane material which is rotatably mounted on a turret assembly upon which a second back-up roll of elastomeric membrane material is also mounted. After being unrolled, the film backing is separated from the membrane and the membrane is introduced into a novel tenter apparatus which controllably, biaxially stretches the membrane material. Following the stretching step, the membrane is automatically cut and then sealed between the cover components and base components of the cover and base arrays. The finished, individual infusion devices are then separated from the arrays and automatically packaged for shipping.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to methods and apparatus formaking fluid delivery devices for infusing medicinal agents into anambulatory patient at specific rates over extended periods of time. Moreparticularly, the invention concerns a novel method and apparatus forthe large volume manufacture of small, disposable fluid delivery devicesfor infusion of medicinal agents into a ambulatory patient.

1. Discussion of the Prior Art

Many medicinal agents require an intravenous route for administrationthus bypassing the digestive system and precluding degradation by thecatalytic enzymes in the digestive tract and liver. The use of morepotent medications at elevated concentrations has also increased theneed for accuracy in controlling the delivery of such drugs. Thedelivery device, while not an active pharmacologic agent, may enhancethe activity of the drug by mediating its therapeutic effectiveness.Certain classes of new pharmacologic agents possess a very narrow rangeof therapeutic effectiveness, for instance, too small a dose results inno effect, while too great a dose results in toxic reaction.

In the past, prolonged infusion of fluids has generally beenaccomplished using gravity flow methods, which typically involve the useof intravenous administration sets and the familiar bottle suspendedabove the patient. Such methods are cumbersome, imprecise and requirebed confinement of the patient. Periodic monitoring of the apparatus bythe nurse or doctor is required to detect malfunctions of the infusionapparatus.

The fluid delivery devices made in accordance with the method of thepresent invention overcome many of the drawbacks of the prior art bymaking use of advanced types of prestressed elastomeric films which, incooperation with a base, define a fluid chamber that contains the fluidwhich is to be dispensed. The prestressed elastomeric film membrane,which is further distended during the filling of the fluid chamber,controllably forces fluid within the chamber outwardly of the device asthe membrane moves toward its less distended stating configuration.

The elastomeric film materials used in the fluid delivery devicesmanufactured in accordance with the methods of the present invention, aswell as various alternate constructions of the fluid delivery devicesthemselves, are described in detail in U.S. Pat. No. 5,205,820 issued tothe present inventor. Therefore, U.S. Pat. No. 5,205,820 is herebyincorporated by reference in its entirety as though fully set forthherein. Co-pending U.S. Ser. No. 08/451,520 filed by the presentinventor on May 26, 1995 also describes several alternate constructionsof fluid delivery devices that can be manufactured in accordance withthe teachings of the present invention. This co-pending application,which also discloses an apparatus for making fluid delivery devices onan individual basis, is also hereby incorporated by reference in itsentirety as though fully set forth herein.

As will be better appreciated from the discussion which follows, themethods and apparatus of the present invention are ideally suited forthe large-scale manufacture of fluid delivery devices of the characterdescribed herein and in application Ser. No. 08/451,520. These deliverydevices typically comprise a base assembly and a stored energy meansprovided in the form of a thin, prestressed, distendable, elastomericmembrane which after being cut in a manner described in Ser. No.08/451,520, cooperates with the base assembly to form a fluid reservoir.Contained within a cavity formed in the base assembly is circuitouslyshaped, hollow cannula which includes an inlet in communication with thefluid reservoir and an outlet formed in a needle-like segment, whichextends generally perpendicularly downward from the lower surface of thebase assembly for subdermal infusion of medicinal fluids into thepatient.

The novel fluid delivery devices manufactured in accordance with thepresent invention have an extremely low profile and are eminentlycapable of meeting the most stringent of fluid delivery tolerancerequirements. The devices are small, easy to use and, in accordance withthe method of the present invention, can be manufactured in very largequantities at low cost.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a method andapparatus for the high volume manufacture of fluid delivery deviceswhich embody a self-contained, stored-energy source for expelling fluidsfrom the reservoir of the device into an ambulatory patient at preciselycontrolled rates over extended periods of time.

It is another object of the invention to provide a method and apparatusof the aforementioned character in which the self-contained,stored-energy source comprises an elastomeric membrane and in which thefluid dispensing devices are manufactured in arrays each arraycomprising a cover array which is superimposed over and connected to abase array with the elastomeric membrane being captured therebetween.

Another object of the invention is to provide an apparatus for thecontinuous assembly of fluid delivery devices of the character describedin the preceding paragraphs in which the elastomeric membrane materialwhich forms the stored-energy source is continuously unrolled from alarge roll of film-backed material which is rotatably mounted on aturret assembly upon which a second back-up roll of elastomeric membranematerial is also mounted.

Another object of the invention is to provide an apparatus of thecharacter described in the immediately preceding paragraph which furtherincludes membrane splicing means for splicing together the end of theprimary roll and the beginning of back-up roll of the rolls mounted onthe turret assembly.

Another object of the invention is to provide an apparatus as describedwhich includes a novel tenter apparatus for controllably, biaxiallystretching the membrane material following its removal from the rolls ofmembrane material carried by the turret assembly.

Another important object of the invention is to provide a method andapparatus of the character described in which, without interrupting theforward travel of the biaxially stretched, elastomeric membrane, themembrane is automatically sealably captured between the cover and basearrays.

Another object of the invention is to provide a method and apparatus ofthe class described in which, following assembly of the variouscomponents of the infusion devices, the finished devices areautomatically labeled and packaged for shipment.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generally perspective view of a cover array comprising aplurality of individual covers of the fluid delivery devices which areto be produced in accordance with the method of the present invention.

FIG. 2 is a generally perspective view of a base array comprising aplurality of base assemblies of the fluid delivery devices which are tobe produced in accordance with the method of the invention.

FIG. 3 is a generally perspective view similar to FIGS. 1 and 2, butshowing a length of biaxially stretched, elastomeric membrane disposedintermediate the cover and base arrays.

FIG. 3A is a generally perspective view showing the appearance of thearray of fluid delivery devices constructed by sealably bonding togetherthe base, the cover and elastomeric membrane components shown in FIG. 3.

FIG. 4 is a generally perspective view of one of the individual fluiddelivery devices of the array shown in FIG. 3A after being separatedfrom the connecting sprues.

FIG. 4A is a side-elevational, cross-sectional view of the individualfluid delivery device shown in FIG. 4 and produced in accordance withthe method of the invention.

FIG. 4B is a generally perspective, exploded view of the device shown inFIG. 4.

FIGS. 5A, 5B, and 5C when considered together, in the manner illustratedin FIG. 5D comprise a side-elevational view of one form of the apparatusof the present invention for the continuous assembly of the variouscomponents of the fluid delivery device shown in FIG. 4. Moreparticularly, FIG. 5A shows the operator control portion of theapparatus along with the support means for rotatably supporting primaryand back-up rolls of elastomeric membrane from which the energy sourceof the fluid dispensing device of FIG. 4A is formed and the lower arrayinput feeder. FIG. 5B illustrates the splicer subassembly, the tensiondancer arm, the membrane accumulator subassembly; membrane stretchingmeans of the apparatus of the invention for controllably stretching theelastomeric membrane to form a prestressed membrane having internalstresses formed therewithin. Also shown in FIG. 5B is a portion of theupper and lower in feed array assemblies, a portion of the arraytake-off assembly, the sealing means and a portion of the over and underwalking beam assembly of the invention for sealably interconnecting thecover components of the cover array shown in FIG. 1 with the basecomponents of the base array shown in FIG. 2. FIG. 5C is aside-elevational view showing portions of the positioning means forpositioning the cover array with respect to the sealing means of theinvention. Also illustrated in FIG. 5C is one form of the upper arrayinput assembly, the array take-off assembly and the packaging, labelingand sealing portion of the apparatus for final packaging of the fluiddispensing devices produced in accordance with the method of theinvention.

FIGS. 6A, 6B, and 6C when considered together, comprise a top plan viewof the apparatus of the invention shown in FIGS. 5A, 5B, and 5C.

FIGS. 7A, 7B, and 7C when considered together, comprise a generallyperspective view of the apparatus of the invention shown in FIGS. 5A,5B, and 5C.

FIG. 7D is a generally perspective, fragmentary view similar to FIG. 7A,but showing in greater detail the support means of the invention forsupporting the rolls of elastomeric membrane material. Also shown ingreater detail is the splicing means of the invention for splicingtogether lengths of elastomeric membrane and also showing in greaterdetail the dancer arm assembly of the invention which monitors andmaintains proper speed and tension on the elastomeric membrane as itadvances forwardly of the apparatus. Further shown is the membraneaccumulator assembly of the invention.

FIG. 7E and 7F when considered together comprise a fragmentary,generally perspective view showing in greater detail the membranestretching means or tenter apparatus of the invention also shown in FIG.7B.

FIG. 8 is an end view of the right end of the apparatus of the inventionas viewed in FIG. 6C.

FIG. 9 and FIG. 9A when considered together in the manner illustrated inFIG. 9B comprise a fragmentary, generally perspective view of the upperarray input assembly of the apparatus.

FIG. 10 is a fragmentary, generally perspective view of thereciprocating assembly shuttle which cooperates with the sonic bondingmeans of the apparatus to bond together the cover and base components.

FIG. 11 is a fragmentary, generally perspective view of the lower arrayinput assembly.

FIG. 12 is a generally diagrammatic, perspective view illustrating theposition of the various subassemblies of the component assemblyapparatus of the invention as they appear at the start of an assemblysequence.

FIG. 13 is a generally schematic, perspective view similar to FIG. 12,but showing the position of the subassemblies as they appear at aninterim step of the assembly process.

FIG. 14 is a generally diagrammatic, perspective view illustrating theposition of the cooperating subassemblies of the apparatus during thebonding step wherein the cover components are bonded to the basecomponents.

FIG. 15 is a generally diagrammatic, perspective view illustrating theposition of the subassemblies of the apparatus following completion ofthe bonding step and prior to the commencement of the packagingoperation.

FIG. 16 and 16A when considered together in the manner illustrated inFIG. 16B comprise a generally diagrammatic, perspective viewillustrating the position of the subassemblies of the apparatus at thecommencement of the final packaging step.

DESCRIPTION OF THE INVENTION

Referring to the drawings and particularly to FIGS. 4 and 4A, oneembodiment of the infusion device produced in accordance with the methodof the invention is there shown and generally designated by the numeral14. As best seen in FIG. 4A, the infusion device, which functions tocontrollably infuse medicinal agents into an ambulatory patient,comprises a base component or assemblage 16 which includes a base member16a. Base member 16a has an upper surface 18, which includes a centralportion 18a, and a peripheral portion 18b. Formed within base member 16is a cavity or chamber 20, the purpose of which will presently bedescribed.

Sealably interconnected with base component 16 is a cover component 22having a generally toroidal shaped cavity 24 formed therein. Sealablycaptured between base component 16 and cover component 22 is aprestressed elastomeric membrane 27. Membrane 27, which comprises thestored energy source of the device, is distendable by fluids underpressure introduced into the device from a generally planarconfiguration into a distended configuration of the character shown inFIG. 4A. When so distended, membrane 27, in cooperation with the uppersurface 18 of the base component, forms a generally toroidal-shapedfluid chamber 30.

Also forming a part of base assembly 16 is cannula means forcontrollably delivering fluid from reservoir 30 to an ambulatorypatient. The cannula means here comprises a generally spiral-shaped,hollow cannula 32 having an inlet 34 in communication with reservoir 30and an outlet defined by a needle-like piercing extremity 36. Disposedintermediate inlet 34 and outlet 36 is a spiral body portion 38 which issupported within chamber 20 of the base component.

With the cannula means appropriately mounted within chamber 20, a needlecap assembly 40 is connected to base 16a. Needle cap assembly 40 herecomprises a base portion 40a which is affixed to base 16a and a sheathportion 40b which functions to encapsulate the piercing extremity 36 ofthe cannula. Formed between base portion 40a and sheath portion 40b isserration 40c which permits the sheath portion to be broken away fromthe body portion at time of use to expose extremity 36.

During use of the device and after the reservoir of the apparatus hasbeen filled with the appropriate beneficial agent to be infused whichcauses membrane 27 to distend to the position shown in FIG. 4A, thesheath of the needle cap assembly 40 can be separated from theassemblage by breaking it along the serration 40c. This done, the devicecan be easily interconnected with the patient by penetrating thepatient's skin with the piercing extremity 36 of the cannula means. Asthe patient's skin and tissue is penetrated by the infusion needle, anadhesive pad 39 provided on the lower surface of the base 16a will causethe base component to adhere to the patient's skin. In some instances,it is desirable to provide a protective peel layer over the adhesive paduntil the time the device is to be used. In such instances, theprotective layer is peeled from the lower surface of base 16aimmediately prior to use of the device.

With the infusion device securely interconnected with the patient, andwith the sheath 40b removed from the base component, distendablemembrane 27 will tend to return to its less distended configuration dueto the internal stresses formed in the membrane during the reservoirfilling step. As the distendable membrane moves toward base 16a, thefluid contained within reservoir 30 will flow into the patient at aprecisely controlled rate. In this regard, it is to be noted thatelastomeric membrane materials suitable for use as the stored energymeans must possess certain physical characteristics in order to meet theperformance requirements for a fluid delivery apparatus. Moreparticularly, for good performance, the elastomeric membrane materialmust have good memory characteristics under conditions of highexpansion; good resistance to chemical and radiological degradation; andappropriate gas permeation characteristics depending upon the endapplication to be made of the device. Reference should be made toapplication Ser. No. 08/451,520 which is incorporated herein byreference for more details concerning the construction and operation ofthe infusion device 14 including details concerning the nature of thestored energy source, the cannula means, and the protective needle capassembly and for details concerning the materials suitable for use inconstructing the base and cover components.

Turning next to FIGS. 1, 2, and 3, in accordance with one form of themethod of the invention, the infusion devices 14 are produced in largevolume by a continuous process whereby injection molded base arrays andcover arrays of the character shown in FIGS. 1 and 2 of the drawings aresealably interconnected together using the apparatus of the invention.One form of the cover array of the invention is shown in FIG. 1 anddesignated by the numeral 44 while one form of the base array of theinvention is shown in FIG. 2 and is designated by the numeral 46.

Cover array 44 comprises a plurality of adjacent cover components 22each of which is interconnected with an adjacent cover component 22 byat least one sprue element 48. Similarly, base array 46 comprises aplurality of adjacent base components 16 each of which is interconnectedwith an adjacent base component by one or more sprue elements 50. Asindicated in FIG. 1, the outer sprue elements 48 are interconnected witha circumferentially extending sprue-like member 48a while the outer mostsprue elements 50 of the base array are interconnected with acircumferentially extending sprue-like element 50a (FIG. 2).

As will be discussed in greater detail hereinafter, during the assemblyof the cover and base arrays in accordance with one form of the methodof the invention, the cover array is superimposed over the base arraywith the elastomeric membrane 27 disposed therebetween in the mannershown in FIG. 3. In accordance with the method of the invention, thecover components 22 and the base components 16 are then interconnectedand sealably bonded together to form the product array shown in FIG. 3Aand generally designated by the numeral 54. Product array 54 comprises aplurality of interconnected together, fully assembled fluid deliverydevices of the character previously described, each having a covercomponent 22, a base component 16 having a downwardly extending cannulaassembly, including a protective sheath 40, and a portion of theprestressed elastomeric membrane 27 captured therebetween. In accordancewith the method of the invention, following the assembly operation, theassembled fluid delivery devices 14 are separated from the sprue members50 to form a plurality of individual final product, fluid dispensingdevices of the general character illustrated in FIG. 4. The specificdetails of the novel method of the invention whereby the covercomponents and the base components are sealably interconnected to formthe array shown in FIG. 3A will be discussed further in the paragraphswhich follow.

Turning next to FIGS. 5A, B, and C; 6A, B, and C; and 7A, B, and C, oneform of the apparatus of the present invention for continuous assemblyof the various components of the fluid delivery device 14 is thereshown. Turning particularly to FIGS. 5A and B, 6A and B, and 7A and 8,the operator control means and part of the support means of one form ofthe apparatus of the invention is there shown. The control means forcontrolling and monitoring the various component assembly mechanisms ofthe apparatus is generally designated as 60 in FIGS. 5A, 6A and 7A, and7B and C. Means 60 here comprises a systems control monitor 62, anoperations monitor 64, an operator keyboard input station 66, and anoperator data tablet input station 68. For convenience, these operablyinterconnected monitoring and input devices are mounted in a mobileframework 70 of the character shown in FIGS. 5A, 6A, and 7A. Controlmeans 60 is constructed from conventional, commercially availabledevices of a character well known to those skilled in the art, and theinterconnection and operation of these devices is well understood.

Shown in the right-hand portions of FIGS. 5A, and 6A and in all of FIGS.5B and C; 6B and C; and 7B and C are the various cooperatingsubassemblies which make up the component assembly means of theinvention for assembling together the several components which make upthe fluid delivery device 14. These subassemblies are mounted within anelongated framework 71 having a first end 71a and a second end 71b.

The first subassembly of the component assembly means of the inventionconsists of a novel support means of the character shown in theright-hand portions of FIGS. 5A, 6A, and 7A and the left-hand portionsof FIGS. 5B, 6B, and 7B. The important support means of the inventionfunctions to rotatably support primary and back-up rolls 72 and 74 offilm-backed lengths of elastomeric material. As best seen in FIGS. 5A,7B and 7D, rolls 72 and 74 are mounted on a novel turret assembly 76which is supported proximate the first end 71a of the supportingframework 71 and includes a turret plate 78 that can be controllablyrotated about a central rotational axis 80. Mounted on plate 78 is apair of spaced apart spindles 82 and 84. Spindle 82 rotatably supportsback-up roll 72 while spindle 84 rotatably supports primary roll 74. Aloading means, best seen in FIGS. 5A, 5B, 7B and 7D, is provided in theform of a roll loading subassembly 86, including a lift mechanism 86a,which can be used to conveniently load the film-backed rolls ofelastomeric material onto spindles 82 and 84.

In carrying out the method of the invention, the driving motors of thevarious operating mechanisms of the apparatus are energized using acontrol panel 75 of conventional construction. When the mechanisms areoperating, a warning light 75a is illuminated. As an initial step, theelastomeric membrane is removed from roll 74 by the membrane removalmeans of the invention in the manner shown in FIG. 5B so that theunstretched elastomeric membrane 27a is separated from the backer sheet27b. More particularly, as the membrane 27a is unrolled from roll 74,the backing film 27b is rolled about a film take-up roll assembly 90which is positioned proximate turret assembly 76. After being unrolledfrom roll 74, the membrane passes through a novel splicing meansgenerally designated in FIG. 5B by the numeral 92. This splicing meansis of generally conventional construction and functions to splicetogether the ends of the elastomeric membranes which make up the primaryand back-up rolls. For example, when roll 74 is exhausted, the endthereof will be stopped at a predetermined position within the splicingmeans 92. The turret assembly 76 will then be rotated so that roll 72 ismoved into the feed position previously occupied by roll 74. With roll72 in the feed position, a length of elastomeric membrane is removedfrom the roll, passed under film roller 95a, placed upon splicing table92a, and then inserted into the splicing means 92 where it will bespliced together with the inboard end of roll 74. Following the splicingoperation, forward travel of the unstretched membrane can then continuewith the membrane moving forwardly of the apparatus and with the backing27b of roll 72 being continuously taken up by take-up roll assembly 90.

After the unstretched elastomeric membrane 27a passes through thesplicing means, it is entrained over a guide roller 95b and under adancer arm roller 96a which roller forms a part of the dancer armassembly 96 of the invention. The dancer arm assembly comprises, inaddition to roller 96a, a dancer arm assembly 98 which pivots about apivot arm 100 (FIGS. 5B and 7D). The dancer arm assembly feeds onaccumulator assembly 97 which comprises a plurality of longitudinally,spaced-apart rollers 102 which, along with dancer arm assembly 98 (FIGS.5B and 7D), function to monitor and maintain the proper speed andtension on the membrane 27a as it advances forwardly of the apparatustoward the second end thereof 71b. Dancer arm assembly 96 andaccumulator assembly 97 are generally of a character known to thoseskilled in the art and their operation is well understood by thoseengaged in continuous film processing operations.

As the unstretched membrane 27a continues its forward travel of theapparatus due to the urging of the membrane removal means, it will enterthe important biaxial stretching means of the invention which comprisesa part of the membrane removal means and which functions to controllablyprestress the membrane to form the prestressed membrane 27 used in theproduction of the infusion devices 14. The biaxial stretching means,which removes the membrane from the rolls of the support means andcontrollably stretches it, can take several forms, but preferablycomprises a tenter apparatus 107 of the general character best seen inFIG. 5B, 6B, 7B, and 7D of the drawings.

While a number of different types of tenter apparatus have beensuggested in the past and their design and operation is well known, atenter apparatus of the general character described in German patent1,504,479 issued to Erwin Kampf can be used in modified form toaccomplish the biaxial stretching step of one form of the method of theinvention.

As best seen in FIG. 7E, as the unstretched membrane 27a is unrolledfrom roll 74, it is introduced into the tenter apparatus 107 in a mannersuch that the edges of the membrane are securely gripped by upper andlower anvils of gripping clamps 110. These gripping clamps are, in turn,operably associated with transversely spaced-apart elongated endlesschain assemblies 112 and 114 which travel along guide rails 112a and114a respectively (see also FIG. 6B). As the chains move about rotatingsprockets 116 and 118 and toward differential screws 120 and 122, thegripping clamps urge the membrane forwardly of the apparatus and divergeoutwardly so as to controllably impart biaxial stretching forces to themembrane 27a causing it to be controllably stretched both transverselyand longitudinally, that is in both an axial direction and a transversedirection to establish the require strain energy density for themembrane. More particularly, the biaxial stretching is accomplishedsimultaneously in the machine direction orientation (MDO) and in thetransverse direction orientation (TDO) (FIG. 6B). It is to be understoodthat the stretching ratios can be precisely tailored to each axis toprovide the desired initial strain energy density and extension patternof the distendable membrane. Under certain circumstances, the extensionvalues for the MDO axis may be different than the extension values forthe TDO axis. It is to be appreciated, however, that in certaininstances, no prestretch of the membrane will be desired and the tenterframe apparatus will not be used. As the distendable membrane 27a isstretched to produce a prestressed membrane 27 of the desired biaxialdimension, it travels forwardly of the apparatus due to the urging ofthe membrane removal means at a uniform controlled first rate of speed.

The next step in the method of the invention, is the important infusiondevice assembly step wherein the prestressed membrane is sealablycaptured between the individual base components 16 of the base arraysand the individual cover components 22 of the cover arrays. This uniqueassembly step is accomplished without process interruption as theprestressed membrane travels forwardly of the apparatus in a directiontoward an end take-up roller assembly 127 (FIG. 12) mounted proximatethe second end 71b of the supporting framework 71. Roller assembly 127,which receives and rolls up the waste membrane that remains after thedevices 14 have been assembled, comprises a part of the membrane removalmeans of the invention (FIGS. 5C and 7C). In a manner next to bedescribed, the assembly of the prestressed membrane with the base andcover components of the infusion device, is uniquely accomplishedcontinuously and "on the fly" without any interruption of the uniformforward travel of the prestressed membrane.

The first step in the device assembly step is accomplished using thefirst positioning means of the invention which functions to sequentiallyposition cover arrays of the character shown in FIG. 1 in closeproximity with the novel sealing and bonding means of the apparatus, thenature of which will presently be described. As will also be furtherdescribed in the paragraphs which follow, at the same time that thecover components of the cover arrays are being positioned proximate thesealing means, the base arrays of the character shown in FIG. 2 arebeing sequentially positioned by a second positioning means at alocation below the moving membrane and in alignment with the coverarrays.

The first positioning means of the apparatus of the invention, which isbest shown in FIGS. 5C, 6C, 7C and 9, comprises a cover array inputhopper assembly 130 and a cover array sprue punch assembly 132, both ofwhich are mounted on a frame 134 that is superimposed over an openframework 136 which includes an array supporting table 137 that isreciprocally movable longitudinally of the framework by a pneumaticassembly generally designated in the drawings by the numeral 138 whichincludes operating airlines 138a which are connected to a suitablesource of air under pressure (see particularly FIG. 9). Pneumaticassembly 138 is of a character well known to those skilled in the art,and the components thereof are readily commercially available fromsources such as compact Air Products of Westminster, S.C.; Robohand,Inc. of Monroe, Conn.; and Watts Fluid Air, of Kittery, Me. Table 137,which is slidably disposed internally of frame 136, includes a pair ofgrid-like sections 140, each of which is provided with a plurality ofrectangular shaped openings 140a which are sized and arranged to closelyreceive the individual cover components 22 of cover arrays 44 of thecharacter shown in FIG. 1. Strategically positioned below frame 136 is abacking plate 142 which is vertically movable from the position shown inFIG. 9 to an upraised position wherein the plate is positionedimmediately below frame 136 in a manner to provide a floor to each ofthe openings 140a formed in grid sections 140.

After the cover arrays 44 have been sequentially removed from inputhopper assembly 130 and have been positioned directly over grid-likesections 140, table 137 is moved to the left as viewed in FIG. 9 bysuitable pneumatic means 138a (FIG. 5C) to a position where one of thecover arrays is disposed immediately below the cover array sprue punchassembly 132. Activation of the punch assembly will cause the punchinghead 132a thereof to move into engagement with and cleanly cut away thesprues 48 of the cover array. After the sprues are cut away from thefirst cover portion, the second cover portion is moved to a locationbelow the sprue punch assembly and the sprues are similarly cut awayfrom this array. The sprues which are removed from the cover arrays willreside on upper cover sprue removal 144 for removal from the apparatusby vacuum removal means of a conventional nature which includes adisposal chute 145 (FIG. 8). The vacuum removal means also comprisescylinders 144a which urge sprue removal 144 toward chute 145.

Also forming a part of the first positioning means of the invention is acover array shuttle means, generally designated in FIG. 9 by the numeral146. This shuttle means includes a shuttle plate 148 which isreciprocally movable longitudinally of the apparatus by a conventionaltype of pneumatic assembly identified by the numeral 150 (FIG. 9). Plate148 is also movable by a second pneumatic lifting assembly 152 from afirst lowered position shown in FIG. 9 to a second upper positionwherein the plate resides in a coplanar relationship with plate 142.After the sprue portions 48 have been removed from a given cover arrayand with the cover components resting on plate 142 and entrapped withinopenings 140a of one of the grid sections 140, shuttle plate 148 ismoved into close proximity with plate 142 and in a co-planarrelationship therewith. With the plates in this position, a movement oftable 137 to the left as viewed in FIG. 9, will cause the covercomponents which are entrapped within openings 140a to slide ontoshuttle plate 148. With the cover components thusly positioned onshuttle plate 148, activation of the pneumatic assembly 150 will nextmove the cover components into close proximity with the sealing means ofthe invention, the construction of which can best be seen by referringin FIG. 10. A 16-unit tray, input 153 is shown in FIGS. 5C and 7C of thedrawings to input packaging trays for containerizing this completeddevice.

Referring to FIGS. 5B, 6B, 7B and 10, the sealing means of the presentform of the invention can be seen to comprise a sonic bonding means 156which includes a pair of sonic bonding head and horn assemblies 158 of aconventional construction. Assemblies 158, which are commerciallyavailable from sources such as Forward Technology Industries ofMinneapolis, Minn. and Dukane Corp. of St. Charles, Ill. are verticallymovable relative to a supporting frame 160 by a plurality ofsimultaneous pneumatically operated, cylindrically shaped assemblies162, which, like assemblies 158, are also of a character well known tothose skilled in the art. It is important to note that the sonic bondingmeans 156 is superimposed directly over the forwardly travelingprestressed membrane 27 and, by means of a motorized servo electricmechanical ball screw assembly 164 can be moved synchronously therewithat a first rate of speed. More specifically, servo electric mechanicalball screw assembly 164 is connected to and reciprocally moves a baseframe 166 of a character shown in the drawings which functions tosupport the sonic bonding head assemblies 158 as well as the pneumaticcylinders 162.

As will be discussed in greater detail hereinafter, after the covercomponents 22 of the cover arrays 44 have been positioned on shuttleplate 148, concomitant movement of shuttle plate 148 and sonic bondinghead assemblies 158 will permit the cover components to be positioneddirectly below a vacuum capture means associated with the sonic bondinghead assemblies 158. When the cover components are captured by thecapture means, the covers will, of course, move with the sonic bondingmeans as it first accelerates and then travels synchronously withmembrane 27 toward the second end of the apparatus.

The second positioning means of the invention, which functions tostrategically position a plurality of base arrays 46 below the movingelastomeric membrane 27, here takes the form of a base array positioningassembly of the character best seen in FIGS. 5B and 11. Referringparticularly to FIGS. 11 and 12, this important positioning assembly canbe seen to comprise a lower base array input hopper 170 which is adaptedto store and then sequentially dispense individual base arrays 46 of thecharacter illustrated in FIG. 2. Also forming a part of the secondpositioning means of the invention is a conveyor assembly 172 whichincludes a conveyor belt 174 upon which the individual base arrays 46are sequentially received from input hopper 170. As the base arrays areplaced in tandam on belt 174 and are carried forwardly of the apparatusby belt 174, pairs thereof will be sequentially picked up by pick andplace means, shown here as a novel pick up and place subassemblygenerally designated in FIG. 11 by the numeral 176. This pick and placeassembly includes a vacuum operated capture plate 178 for picking upeach pair of arrays and also includes pneumatic means 179 forcontrollably moving the capture plate longitudinally of the apparatus atthe same rate of speed as the speed of travel of conveyor belt 174. Withthis construction, each of the pairs of base arrays 46 can besequentially picked up from the conveyer 174 and expediciouslytransported to novel, centrally disposed lower walking beam shuttlemeans generally designated in FIG. 10 by the numeral 180. Shuttle means180 includes a deck 182 which supports a pair of vertically movable basearray support platforms 184. Deck 182 along with platform 184, is movedlongitudinally of the apparatus by a conventional screw assemblygenerally designated in FIG. 10 by the numeral 186. In a mannerpresently to be described, after the base arrays have been positioned intandum on the elevator platforms 184 of the central lower walking beamshuttle means, platform 182 will accelerate and then be movedsynchronously with both membrane 27 as it travels forwardly of theapparatus and with the bonding means of the apparatus as it also travelsforwardly of the apparatus at the same speed of travel as membrane 27.With this novel arrangement, when the cover components, which arecarried by sonic bonding head assemblies 158 move into alignment withthe base arrays, which are supported on platforms 184, the elevatorplatforms will be moved upwardly toward the lower surface of prestressedmembrane 27. At precisely the same time, sonic bonding assemblies 158,along with the cover components 22 carried thereby, will move downwardlytoward the upper surface of forwardly moving membrane 27. When the covercomponents, pressurally engage the upper surface of the membrane and thebase components simultaneously pressurally engage the lower surface ofthe forwardly traveling membrane, the membrane 27 will be cut along aline defined by a circular-shaped protuberance 187 formed on basecomponent 16 (FIG. 3). (See also Ser. No. 08/451,520). Simultaneously,the sonic bonding heads will be energized so as to sonically bondtogether the cover components and the base components with the portionsof the prestressed membranes which are cut away being sealably capturedtherebetween. In this regard, protuberances 187, which are generally "V"shaped in cross section, not only cut the membrane, but also act asenergy directors to facilitate the sonic bonding of the cover and basecomponents.

Accomplishment of the method of the invention for continuous assembly ofthe infusion devices 14 can be best understood by referring to FIGS. 12through 15. Referring particularly to FIG. 12, the various cooperatingmechanisms of the component assembly means of the invention are shown ina starting position at which the first step in the component assemblymethod of the invention can be commenced. More particularly, as shown inFIG. 12, shuttle plate 148 of the first positioning means of theinvention is empty and ready to receive cover components from plate 142of the sprue removal means. Similarly, the elevator platforms 184 ofshuttle means 180 are empty and ready to receive base component arrayswhich have been dispensed from base array hopper 170 onto the surface ofconveyor belt 174. Turning to FIG. 13, the phantom lines of this drawingshow the cover components which have been transferred from transferplate 142 to shuttle plate 148 by movement of table 137 to the left. Thesolid lines reflect the movement of platform 148 into a positiondirectly below and in close proximity with sonic bonding head assemblies158. With the cover components in this position, they are ready forcapture by the vacuum capture means carried by the sonic bondingapparatus 158. The phantom lines in the lower left hand portion of FIG.13 show the pickup and place subassembly 176 in position over a pair ofbase arrays which have been taken from hopper assembly 170 andpositioned in tandum on conveyor belt 174. Also shown in phantom linesat the lower right of the FIG. 13 is the centrally disposed lowerwalking beam shuttle means of the invention with the previouslyassembled infusion devices 14 having been removed therefrom by theproduct removal shuttle or product pick up and place subassembly of theapparatus of the invention which is generally designated in FIG. 13 bythe numeral 190. The solid lines in FIG. 13 show the central lowerwalking beam shuttle assembly 180 located in a position ready to receivethe base arrays which have been picked up and transferred by the pickupand place subassembly 176, which is also shown in solid lines.

Turning to FIG. 14, the important sonic bonding step of the method isthere illustrated. More particularly, the sonic bonding head assemblies158 which carry the cover components are shown in a position inalignment with the base components carried by the elevator platforms 184and moved upwardly into close proximity with the lower surface ofmembrane 27. It is to be noted that this step has been accomplished withthe sonic bonding assemblies 158 and the elevator platforms 184 beingfirst accelerated and then moved synchronously forwardly of theapparatus at the same rate of speed as and synchronously with membrane27. As previously mentioned, as the cover components and the basecomponents come into pressural engagement with the elastomeric membrane27, the membrane will be cut along the circular shaped energy directors187 provided on the upper surface of the base components. At this sameinstant in time, the base components and cover components will be bondedtogether with the cut portion of the membrane sealably capturedtherebetween.

Turning to FIG. 15, which illustrates the post assembly position of thevarious components of the component assembly means, it is to be notedthat the bonding head assemblies have once again been elevated to theiroriginal starting position shown in FIG. 12 and similarly, the elevatorplatforms 184 of the lower walking beam central shuttle means have beenlowered to their original starting position shown in FIGS. 12 and 13.Disposed on the upper surfaces of the elevator platform 184 are thesealably interconnected device arrays 54 which are of the charactershown in FIG. 3A. As indicated by the arrows in FIG. 15, during thispost assembly step, the central shuttle means 180 is moving forwardly ofthe apparatus while the final product pickup and place assembly 190 ismoving in the opposite direction due to the urging of pneumaticoperating means 190a of conventional construction. This movement of thepickup and place assembly 190, as shown by the arrows of FIG. 15, willcontinue until the finished product arrays 54 disposed on platforms 184are directly below the pickup and placement assembly 190. At thisinstant in time, the vacuum plate 190b of the pickup and placementassembly 190 will be lowered and the finished product arrays 54 will becaptured. This done, travel of the final product pickup and placementassembly 190 will be reversed so that the final product arrays can besuperimposed over and strategically placed upon a final product conveyor194 of the character best seen in FIG. 16. As shown in FIG. 16, thefinal product arrays 54 are then carried by conveyor 194 to a finalproduct lower base sprue removal station 197 (FIGS. 5C, 7C, and 16)where the sprues 50, which interconnect the assembled devices 14 are cutaway. Following this sprue removal process, the finished components aretransported to the final product packaging station where they arepackaged for shipment and are removed from the apparatus (FIG. 16).

The sprue cutting operation, wherein sprues 50 are removed from thefinal product arrays, is accomplished by a sprue cutting apparatus ofgenerally conventional construction. Similarly, the packaging step isaccomplished using plastic thermo form tray packaging apparatus of acharacter well known to those skilled in the art which includespackaging the final product in the vacuum formed tray using a thermosealing film material 199 which is dispensed from a roll of sealingmaterial 199a (FIGS. 5C, 7C, and 16). Because these processes are wellunderstood by those skilled in the art, the details of the final sprueremoval process and of the packaging process will not be discussed indetail.

It is to be understood that the various operating subassemblies of thecharacter described in the preceding paragraphs are controllablyoperated by the control means shown in FIGS. 5A, 6A and 7A and generallydesignated as 60.

Having now described the invention in detail in accordance with therequirements of the patent statutes, those skilled in this art will haveno difficulty in making changes and modifications in the individualparts or their relative assembly in order to meet specific requirementsor conditions. Such changes and modifications may be made withoutdeparting from the scope and spirit of the invention, as set forth inthe following claims.

I claim:
 1. A method of simultaneously producing a plurality of devicesfor infusing medicinal fluid into a patient at a controlled rate, eachdevice having a base component provided with an upper surface includinga central portion and a peripheral portion, a distendable, elastomericmembrane superimposed over the base component and a cover componentengageable with the base, the method comprising the steps of:(a) forminga cover array comprising a plurality of spaced-apart cover components;(b) forming a base array comprising a plurality of spaced-apart basecomponents; (c) removing a length of elastomeric membrane from a firstroll of elastomeric membrane; (d) placing said cover array over saidmembrane at a location in alignment with said cover array in a mannersuch that each said base component of said base array is aligned withone of said cover components of said cover array; and (f) simultaneouslysealably connecting together each said cover component with each saidbase component aligned therewith so that a portion of said elastomericmembrane is captured therebetween.
 2. A method as defined in claim 1including the further step of biaxially stretching said membrane afterit is removed from said first roll of elastomeric membrane to form alength of prestressed membrane.
 3. A method as defined in claim 2including the further step of cutting said length of prestressedmembrane as the cover component is emplaced over the base component. 4.A method as defined in claim 2 in which each said cover component issealably connected by bonding to said base component aligned therewith.5. A method as defined in claim 4 in which said cover component issealably bonded to said aligned base component along the peripheralportion of the base component.
 6. A method of making a plurality ofdevices for infusing medicinal fluid into a patient at a controlledrate, each said device having a base component provided with an uppersurface including a central portion and a peripheral portion, adistendable, prestressed elastomeric membrane superimposed over the basecomponent and a cover component engageable with the base, said methodbeing accomplished using a manufacturing apparatus having first andsecond ends, support means disposed proximate the first end of theapparatus for rotatably supporting a rolled length of elastomericmembrane and membrane removal means for continuously removing theelastomeric membrane from the support means and for continuously movingsaid elastomeric membrane toward said second end of said apparatus at afirst rate of speed, said method comprising the steps of:(a) positioninga plurality of cover components over the moving elastomeric membrane andmoving said plurality of cover components synchronously with theelastomeric membrane in a direction toward the second end of theapparatus at the first rate of speed; (b) positioning a plurality ofbase components below the moving elastomeric membrane in alignment withthe plurality of cover components and moving the base componentssynchronously with the elastomeric membrane in a direction toward thesecond end of the apparatus at the first rate of speed; and (c) sealablyinterconnecting each of the plurality of cover components with aselected one of said plurality of base components with a portion of theelastomeric membrane disposed therebetween to form a plurality ofdevices.
 7. A method as defined in claim 6 including the further step ofbiaxially stretching the moving elastomeric membrane to form aprestressed membrane.
 8. A method as defined in claim 7 including thefurther step of cutting said prestressed membrane as the covercomponents are sealably interconnected with the base components.
 9. Amethod as defined in claim 8 in which each cover component is connectedto a base component by bonding.